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SECRETARY THOMPSON URGES STRONG WARNING LABELS FOR EPHEDRA
Department of Health and Human Services (HHS) Secretary Tommy G. Thompson has
asked the Food and Drug Administration (FDA) to evaluate the best
scientific evidence available and recommend the strongest possible
mandatory warning label possible for ephedra products.
In addition, FDA announced a new program to proactively analyze all
herbal ephedra products to ensure that they contain natural ingredients
and not synthetic ingredients as required by law. FDA also noted that
it's illegal for companies to market non-herbal synthetic ephedrine
alkaloid products as dietary supplements.
FDA will analyze ephedra products to determine if natural ingredients
are being used. This is in addition to recent FDA action in June when
the agency issued warning letters to six marketers of products
containing ephedrine compounds that appeared to be synthetically
derived.
FDA also is continuing its efforts to prevent marketers from
advertising ephedra products as alternatives to street drugs. On
October 7, 2002, FDA sent a warning letter to Xoch Linnebank, who
operates a website based in the Netherlands. The website was
advertising the Ephedra product Yellow Jacket as "herbal XTC." The
website said,
"the Yellow Jacket has an extremely stimulating rush, with sensations
one would attribute to E or amphetamines."
Earlier this year, FDA sent a warning letter to Herbtech, which was
marketing two ephedra products as street drug alternatives.
(FDA Release, P02-41, October 8, 2002.)
LABORATORY CHARGED WITH PROVIDING FALSE TEST RESULTS FOR BOGUS ANTHRAX
TEST KIT
A testing laboratory agreed to settle FTC charges over its
role in providing false test results for a purported do-it-yourself
home anthrax test. Sani-Pure Food Laboratories and its partner, Ronald
Schnitzer, provided test data in support of Pur-Test Anthrax Test
(PTAT), the purported anthrax test kit that was the subject of FTC's
action against Vital Living Products, Inc. (Vital Living) earlier this
year. The Sani-Pure test report states that it had conducted tests,
using anthrax, that showed that PTAT was effective for detecting the
presence of anthrax. In fact, Sani-Pure had not used anthrax in its
testing. The settlement bans Sani-Pure and Schnitzer from testing to
detect the presence of a biological or chemical warfare agent and from
misrepresenting test results.
Vital Living began marketing PTAT in October 2001, using ads that
claimed that PTAT was 95% effective in detecting anthrax bacteria and
spores on surfaces, in the air, and in water, both at home and in the
workplace. In November 2001, Vital Living retained Sani-Pure to conduct
testing to validate PTAT's efficacy.
According to FTC, Sani-Pure's test report said that it had tested
PTAT's efficacy at detecting "innoculated samples of bacillus
anthracis" and that the results showed PTAT to be effective. So Vital
Living released promotional materials saying that in testing using
anthrax PTAT was 95% effective, with a false positive rate of 5%. In
fact, according to FTC, Sani-Pure's testing did not evaluate PTAT's
efficacy at detecting anthrax. Instead, Sani-Pure evaluated the
efficacy of the product at detecting colonies of bacillus cereus, a
common environmental contaminant. According to FTC, bacillus cereus is
not an appropriate proxy for anthrax in determining the efficacy of a
test that detects the presence of anthrax. In February 2002, FTC
announced that it had settled charges that Vital Living had
misrepresented PTAT's efficacy.
The matter announced today charges defendants Sani-Pure and Schnitzer
with misrepresenting the results of their tests of PTAT. Specifically,
the complaint alleges that--
defendants falsely represented that Vital Living's anthrax test kit was
effective;
defendants conducted their testing of PTAT using anthrax; and
defendants' test methodology reliably would demonstrate whether PTAT
effectively detected anthrax.
The settlement bans the defendants from testing to evaluate or
determine the presence or absence of a biological or chemical warfare
agents, or evaluating the efficacy of a product designed to detect such
agents.
(Sani-Pure Food Laboratories, et al., FTC File No. 022 3144, Civil
Action No. 02-CV-4608, October 23, 2002.)
ALLEGEDLY DECEPTIVE SPAMMERS SETTLE FTC CHARGES
Operators who allegedly used spam, deceptive earnings claims, and fictitious
testimonials to sell spam e-mail lists as business opportunities agreed
to settle FTC charges that their operations violated federal laws. The
settlements will bar defendants from making false, misleading, or
deceptive claims about their e-mail lists, software, service, marketing
program, or any other business opportunity.
FTC charged that Richard Jon Scott, doing business as Cyber Data, and
Sonya Lockery, doing business as Internet Specialists, sent spam to
consumers claiming that by buying their bulk e-mail lists, consumers
could make easy money selling products and services on the Internet.
Internet Specialists also promoted the spam list on a Web site. Cyber
Data's e-mail claimed that purchasers reasonably could expect to earn
"over $10,000,000" by selling a $5 product via bulk e-mail.
Internet Specialists made similar earnings claims, and its Web site and
e-mail contained earnings claims that appeared to be endorsements from
previous purchasers. FTC charged that both Scott and Lockery made false
earnings claims and falsely characterized the quality of their bulk
e-mail lists. Cyber Data claimed that its e-mail address lists
contained "no duplications," and included "almost every person on the
Internet today."
According to FTC, Internet Specialists falsely claimed that its 11
million e-mail address list consisted of consumers who were "highly
responsive" since they had "either requested to receive e-mail
advertisements or have responded to our ads." It also claimed its lists
contained no duplicates.
The settlements will permanently bar defendants from making any false,
misleading, or deceptive claims about potential earnings from any bulk
e-mail list, software, service, or marketing program, or any other
business opportunity.
The settlement with Cyber Data bars it from claiming that its e-mail
lists contain no duplicates and includes almost everyone on the
Internet today.
The settlement with Internet Specialists also bars the "no duplicate"
claim and bars misrepresentations that the lists include addresses of
individuals interested in receiving bulk e-mail ads.
FTC's order requires Cyber Data to pay $20,000 in consumer redress and
suspends payment by Internet Specialists.
NOTE: Consent judgments are for settlement purposes only and do not
constitute an admission by the defendant of a law violation. Consent
judgments have the force of law when signed by the judge.
(Cyber Fire Power, et al., FTC File No. 022-3031, October 23, 2002;
Internet Specialists, et al., FTC File No. 022-3044, October 23, 2002.)
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